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Assessing HIV Care Outcomes Among Persons Who Use Drugs in Puerto Rico Before and After Hurricane Maria
- Diana Hernández, Yue Pan, Gabriel Cardenas, Sandra Miranda de León, Glenda O. Davila-Torres, Allan E. Rodriguez, Iveth G. Yanez, Mariela Maisonet Alejandro, Wilmarie L. Calderón Alicea, Héctor J. Meléndez-González, Daniel J. Feaster, Lisa R. Metsch, Jorge Santana-Bagur
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- Journal:
- Disaster Medicine and Public Health Preparedness / Volume 17 / 2023
- Published online by Cambridge University Press:
- 24 May 2023, e397
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Objectives:
To explore the health impacts of Hurricane Maria (HM) on HIV care outcomes among people living with HIV who use drugs.
Methods:Using data from an ongoing cohort study in San Juan, Puerto Rico (Proyecto PACTo), we measured differences in HIV care outcomes (viral load, viral suppression, and CD4 counts) before and after HM using assessments conducted at 6-month intervals. Generalized estimating equations were used to assess factors associated with HIV care outcomes.
Results:All HIV care outcomes showed a deterioration from pre-HM values to post-HM values (mean viral load increased, CD4 counts decreased, and rate of viral suppression decreased) after controlling for pre-HM sociodemographic and health characteristics. In addition to HM, age (aIRR = 1·01), being homeless (aIRR = 0·78) and having health insurance (aIRR = 1·6) were independently associated with viral suppression.
Participants:219 participants completed follow-up visits between April 2017 and January 2018, before and after HM.
Conclusions:People living with HIV who use drugs in Puerto Rico experienced poorer HIV outcomes following HM. Socio-environmental factors contributing to these outcomes is discussed in the context of disaster response, recovery, and program planning.
Preference of medicine and patient-reported quality of life in community-treated schizophrenic patients receiving aripiprazole vs standard of care: Results from the STAR study
- David Taylor, Linda Hanssens, Jean-Yves Loze, Miranda Pans, Gilbert L'Italien, Ronald N. Marcus
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- Journal:
- European Psychiatry / Volume 23 / Issue 5 / August 2008
- Published online by Cambridge University Press:
- 16 April 2020, pp. 336-343
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Objective
To evaluate quality of life and patient preference for schizophrenia treatment in a community based study comparing the use of aripiprazole to the standard of care (SOC).
MethodThis open-label, 26-week, multi-centre, randomised study compared aripiprazole with SOC (olanzapine, quetiapine or risperidone) in patients with schizophrenia (DSM-IV-TR criteria). The primary effectiveness variable was the mean total score of the Investigator Assessment Questionnaire (IAQ) at Week 26. The outcome research variables included the Preference of Medicine (POM) questionnaire, the Quality of Life Scale (QLS), and the EuroQoL-5D (EQ-5D). The results from these outcome research variables are the focus of this paper addressing quality of life and patient preference.
ResultsA total of 555 patients were randomised to receive aripiprazole (n = 284) or SOC (n = 271). The OC data at Week 26, reported that more respondents rated the study medication as ‘much better’ compared with their previous medication in the aripiprazole group versus SOC for patients (59% vs 35%, P < 0.001) and caregivers (58% vs 30%, P = 0.014). The improvement in QLS total score was also significantly greater in the aripiprazole group compared with SOC – mean change from baseline in QLS total score of 16.21 vs 10.01 (P < 0.001) at Week 26 (OC data set). A greater proportion of patients (93% vs 85%; P = 0.005) in the aripiprazole group had a satisfactory response on the EQ-5D Self Care Scale; all other EQ-5D scores were similar.
ConclusionThe study findings suggest that quality of life and patient medication preference measures were better for aripiprazole than for SOC.
Ensayo multicéntrico, aleatorio, naturalista y abierto de comparación entre aripiprazol y el estándar óptimo de tratamiento de pacientes esquizofrénicos de la comunidad Ensayo de Aripiprazol en la Esquizofrenia: estudio STAR
- Robert Kerwin, Bruno Millet, Erik Herman, Csaba M. Banki, Henrik Lublin, Miranda Pans, Linda Hanssens, Gilbert L'Italien, Robert D. McQuade, Jean-Noël Beuzen
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- Journal:
- European Psychiatry (Ed.Española) / Volume 15 / Issue 1 / February 2008
- Published online by Cambridge University Press:
- 12 May 2020, pp. 31-42
- Print publication:
- February 2008
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Antecedentes.
Los ensayos naturalistas sobre la efectividad de los antipsicóticos atípicos son necesarios para aportar una información más amplia sobre la eficacia, la seguridad y la tolerabilidad en pacientes con esquizofrenia tratados en un centro médico de la comunidad.
Métodos.En este estudio multicéntrico abierto de 26 semanas, diversos pacientes con esquizofrenia, que necesitaron un cambio en la medicación antipsicótica porque no toleraban bien la medicación actual y/o porque los síntomas clínicos no estaban bien controlados, se aleatorizaron para recibir aripiprazol o un tratamiento estándar (TE) con un antipsicótico atípico (por ejemplo, olanzapina, quetiapina o risperidona en función del juicio del investigador sobre el tratamiento óptimo de cada paciente individual y la respuesta previa del paciente a la medicación antipsicótica). El objetivo principal fue comparar la efectividad de un tratamiento de 26 semanas con aripiprazol con el TE, medido por la puntuación total del Cuestionario de Evaluación del Investigador (IAQ) en la última observación arrastrada (UOA) de la semana 26 (variable primaria), una medida validada que controla el alivio o el empeoramiento de 10 síntomas clave asociados con la psicopatología de la esquizofrenia y los efectos secundarios del tratamiento antipsicótico. Los objetivos secundarios fueron evaluar la efectividad usando las escalas Impresión Clínica Global - Mejoría Global (CGI-I) e Impresión Clínica Global - Gravedad de la Enfermedad, para evaluar el tiempo transcurrido hasta la suspensión del tratamiento, la preferencia del paciente respecto a la medicación, y la calidad de vida y la tolerabilidad de aripiprazol comparado con el TE.
Resultados.El tratamiento con aripiprazol (n=268) fue significativamente más eficaz que el TE (n = 254; P < 0,001; UOA de la semana 26), evidenciado por la puntuación IAQ total, desde la semana 4 (primera fase de evaluación) y se mantuvo hasta la semana 26. Una relación similar se demostró en los pacientes que terminaron el estudio (análisis de casos observados); aripiprazol se asoció con una efectividad significativamente mayor en todas las fases de evaluación con un mayor efecto diferencial de TE con el tiempo. Los pacientes tratados con aripiprazol también tuvieron mejorías significativamente mayores en la escala CGI-I (tasa de rspuesta, P = 0,009 en la UOA de la semana 26), y en la calidad de vida (puntuación total en la escala de Calidad de Vida; P < 0,001 en la semana 26). Además, una proporción significativamente mayor de pacientes que recibieron aripiprazol calificaron la medicación del estudio como “mucho mejor” en la escala del Cuestionario de Preferencias de Medicación (POM) que la medicación anterior al estudio comparados con los pacientes tratados con TE (P < 0,001; semana 26). El tiempo hasta la suspensión del tratamiento y las tasas de suspensión debidas a episodios adversos fueron similares en los dos grupos de tratamiento. La incidencia de pacientes con uno o varios síntomas extrapiramidales (por ejemplo, acatisia, distonía, episodios parkinsonianos y episodios residuales) fue mayor en los pacientes que recibieron aripiprazol comparados con los pacientes tratados con TE (13,5% frente a 5,6%); sin embargo, una proporción mayor de pacientes del grupo TE tuvo un aumento de peso clínicamente significativo (21,2% frente a 7,3% para aripiprazol) y de las concentraciones séricas (potencialmente importantes desde el punto de vista clínico) de colesterol total, colesterol de lipoproteínas de baja densidad, triglicéridos y prolactina comparados con los pacientes que recibieron aripiprazol.
Conclusiones.Aripiprazol es un antipsicótico atípico eficaz para el tratamiento de la esquizofrenia, que ha demostrado más efectividad que los fármacos estándar usados en este estudio en pacientes que necesitaban un cambio en la medicación antipsicótica.
A multicentre, randomized, naturalistic, open-label study between aripiprazole and standard of care in the management of community-treated schizophrenic patients Schizophrenia Trial of Aripiprazole: (STAR) study
- Robert Kerwin, Bruno Millet, Erik Herman, Csaba M. Banki, Henrik Lublin, Miranda Pans, Linda Hanssens, Gilbert L'Italien, Robert D. McQuade, Jean-Noël Beuzen
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- Journal:
- European Psychiatry / Volume 22 / Issue 7 / October 2007
- Published online by Cambridge University Press:
- 07 June 2007, pp. 433-443
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Background
Naturalistic effectiveness trials of atypical antipsychotics are needed to provide broader information on efficacy, safety, and tolerability in patients with schizophrenia treated in a community practice setting.
Methodin this 26-week, open-label, multicentre study, patients with schizophrenia requiring a switch in antipsychotic medication because current medication was not well tolerated and/or clinical symptoms were not well controlled were randomized to receive aripiprazole or an atypical antipsychotic standard of care (SOC) treatment (i.e., olanzapine, quetiapine, or risperidone based on the investigator's judgment of the optimal treatment for the individual patient and the patient's prior response to antipsychotic medication). The primary objective was to compare the effectiveness of a 26-week treatment of aripiprazole versus SOC, as measured by the investigator Assessment Questionnaire (IAQ) total score at Week 26 last observation carried forward (LOCF) (primary endpoint), a validated measure that monitors relief or worsening of 10 key symptoms associated with the psychopathology of schizophrenia and side effects of antipsychotic treatment. Secondary objectives were to further assess effectiveness using the Clinical Global Impression – Global Improvement (CGI-I) and Clinical Global Impression – Severity of Illness scale, to assess time to treatment discontinuation, patient preference of medication, quality of life, and the tolerability of aripiprazole compared with SOC.
ResultsAripiprazole treatment (n = 268) resulted in significantly better effectiveness than SOC treatment (n = 254; P < 0.001; Week 26 LOCF) as evidenced by the IAQ total score beginning at Week 4 (the first assessment point) and sustained through Week 26. A similar relationship was demonstrated among patients who completed the study (observed cases analysis); aripiprazole was associated with significantly better effectiveness at all time points with a greater differential effect from SOC over time. Patients treated with aripiprazole also demonstrated significantly greater improvements on the CGI-I scale (responder rate, P = 0.009 at Week 26 LOCF), as well as on quality of life (Quality of Life scale total score; P < 0.001 at Week 26). Furthermore, a significantly higher proportion of patients receiving aripiprazole rated their study medication as “much better” on the Preference of Medication Questionnaire (POM) scale than their pre-study medication compared with SOC patients (P < 0.001; Week 26). Time to treatment discontinuation and rates of discontinuation due to adverse events were similar in both treatment groups. The incidence of patients with one or more extrapyramidal symptom (e.g., akathisia, dystonia, parkinsonian events, and residual events) was higher in patients receiving aripiprazole compared with patients treated with SOC (13.5% vs. 5.6%); however, a higher proportion of patients in the SOC-treated group had clinically significant weight gain (21.2% vs. 7.3% for aripiprazole) and potentially clinically relevant elevated fasting levels of total cholesterol, low-density lipoprotein cholesterol, triglycerides, and serum prolactin compared with patients receiving aripiprazole.
ConclusionsAripiprazole is an effective atypical antipsychotic for the treatment of schizophrenia, demonstrating better effectiveness than SOC agents used in this study in patients for whom a switch in antipsychotic medication was warranted.